Pharmaceutical Technology, Sep 2, 2013 - Pharmaceutical Technology

Latest Issue

Latest Issue
PharmTech Europe

Pharmaceutical Technology, Sep 2, 2013
Cover Story
Quality by Design in APIs
By Patricia Van Arnum
The adoption of quality by design in small-molecule drug development and manufacturing continues to evolve as the industry seeks ways to augment process understanding for APIs
Featured Content
The Importance of Characterization in Biosimilars Development
By Adeline Siew, PhD
Industry experts discuss the requirements and challenges involved in getting a biosimilar product from bench to launch.
Peer-Reviewed Research
Overcoming Limitations of Vaporized Hydrogen Peroxide
By James P. Agalloco , James E. Akers
Vaporous hydrogen peroxide, used for sterilization and decontamination, is highly potent but presents implementation challenges.
Effective and Efficient Weighing of Potent Compounds
By George Hartford , Patty Cheung , Karen Whitaker , Roy Helmy, PhD , Joanne Ratcliff, PhD
The advantages of using an automated powder dispensing system in a ventilated balance enclosure for efficient handling and effective containment of potent compounds are discussed.
API Synthesis & Manufacturing
Advancing Chiral Chemistry in Pharmaceutical Synthesis
By Patricia Van Arnum
Developments involve stereoretentive cross-coupling, enantioselective alcohol silylation, strategies for amplifying signals in circular dichroism spectroscopy, and a synthetic route for the natural product ingenol.
Regulation & Compliance
FDA Works to Secure Drug Supply Chain
By Jill Wechsler
New FDA supply chain policies aim to strengthen inspection and oversight processes.
EU Raises API Standards: A Curse in Disguise?
By Sean Milmo
The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
Statistical Solutions
The Basics of Measurement Uncertainty in Pharma Analysis
By Chris Burgess
How good is a reportable value?
Insider Solutions
The Elements of Training
By Susan J. Schniepp
Establishing a well-defined training program is a crucial activity for any biopharmaceutical organization.
Best Practices for Restricted Access Barrier Systems
By Joerg Zimmermann
Restricted access barrier systems (RABS) maximize product control but minimize operator interaction in aseptic manufacturing.
Outsourcing Partnerships for CMC Development
By Jim Miller
Are strategic partnerships in clinical research a model for CMC services?
Global Feature
Report from Brazil
By Hellen Berger
Pharma eyes biologics production in Brazil as the government begins to recognize the potential of these drugs.
Ask the Expert
Multivariate Approaches for Powder Characterization
John Yin, an applications specialist with Freeman Technology, discusses the importance of powder-characterization techniques for optimizing pharmaceutical product development and manufacturing processes.
Guest Editorial
The Importance of Continued Investment in R&D
By Mark Howard
There has been a notable shift in interest for life-science companies over recent months from institutional investors investing through the public markets, but any plans to release further capital will rely on first-rate R&D.
Connecting People, Science, and Regulation
By Richard Johnson
PDA/FDA regulatory conference promotes a commitment to quality.
Product Spotlight
Omega Design Corporation Introduces LabelSync 450
Omega Design Corporation offers the LabelSync 450 Vision Module, designed to capture and sync a bottle?s unique serialized label with its individual line code.
Bosspak VTC 100 Tablet and Capsule Counter
The Bosspak VTC 100 electronic tablet and capsule counter from Romaco?s is designed to fill pharmaceutical solids or food supplements into bottles at high speed.
MF40 Automated Punch and Die Polishing Machine
I Holland has introduced the next generation to its range of MF polishers, the MF40 automated punch, and die polishing machine.
XstalBio Introduces CentuRecon
CentuRecon enables dry formulations of therapeutic proteins to quickly be prepared for injection at high concentration.


LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
| Weekly

What role should the US government play in the current Ebola outbreak?
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Finance development of drugs to treat/prevent disease.
Oversee medical treatment of patients in the US.
Provide treatment for patients globally.
All of the above.
No government involvement in patient treatment or drug development.
Jim Miller Outsourcing Outlook Jim MillerOutside Looking In
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerAdvances in Large-Scale Heterocyclic Synthesis
Jill Wechsler Regulatory Watch Jill Wechsler New Era for Generic Drugs
Sean Milmo European Regulatory WatchSean MilmoTackling Drug Shortages
Click here